13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADVANTAGE 4D OPTION
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032915·Baltic Denture System BDLoad ↓ Sm7 PLSEum6DFs B...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746161827·DB BKT MINI MS V-SLOT LR CUSP 022 T-7 A+7 R3D
FLEXIBLE OCCLUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DINAMAP PRO 1000 MONITOR, MODEL 1000
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROMAX-PLUS MOTOR ASSY
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·March 29, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 29, 2011
N'VISION
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·April 23, 2008
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 2017
SURGPN,270X5,HMPMPC,-,LFR-CS,24
FDA Adverse Event
Injury
·HALYARD - IRVINE·Product code MEB·November 26, 2015
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024